Mechanisms of action of hypoglycemic drugs in nonalcoholic fatty liver disease (NAFLD)
Not Applicable
Completed
- Conditions
- onalcoholic fatty liver disease, type 2 diabetesNutritional, Metabolic, EndocrineNon-insulin-dependent diabetes mellitus
- Registration Number
- ISRCTN33414972
- Lead Sponsor
- niversity of Ryukyus (Japan)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 800
Inclusion Criteria
1. Diabetic males aged 40-70 years
2. Previously untreated for type 2 diabetes (T2DM)
3. Body mass index (BMI) >25 kg/m2
4. Glycated hemoglobin (HbA1c) of 6.4-7.9% (National Glycohemoglobin Standardization Program units)
5. Fasting plasma glucose of 126-261 mg/dl
Exclusion Criteria
1. Patients with mental disorders, including alcohol dependence, or with such a history
2. Patients with pancreatitis
3. Patients with malignant diseases
4. Patients with viral hepatitis
5. Patients who have participated in any clinical study or trial within 6 months
6. Patients experiencing a weight gain or loss of 1 kg or more within 3 months before the start of the trial
7. Patients deemed ineligible for the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Differences between baseline and end-of-treatment liver to spleen (L/S) ratios determined by CT and physical findings (blood pressure, body mass index and waist circumference) will be measured in each group.<br>Blood samples will be obtained to measure concentrations of aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transpeptidase (GGT), cholinesterase, fasting plasma glucose, fasting insulin, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol (HDL-C), triglycerides, non-esterified fatty acids (NEFA), high-sensitivity C-reactive protein (hsCRP), soluble tumor necrosis factor receptors 1 (sTNFR-1), and 2 (sTNFR-2), high-molecular-weight (HMW) adiponectin, and ferritin.
- Secondary Outcome Measures
Name Time Method o secondary outcome measures